Chronic myeloid leukaemia (CML) - nilotinib

Authority to supply nilotinib (Tasigna®) through the Pharmaceutical Benefits Scheme (PBS) under the Section 85 Arrangements of the National Health Act 1953.

Nilotinib is available as the sole PBS subsidised therapy for the treatment of patients with chronic myeloid leukaemia (CML), in chronic or accelerated phases, bearing the Philadelphia chromosome or expressing the transcript BCR-ABL and who have active disease (as defined by current bone marrow pathology) and who have failed an adequate trial of imatinib mesylate.

Restriction details

Either of the following two restrictions must apply before approval will be granted to prescribe nilotinib under the PBS:

• initial treatment for patients of CML who have failed an adequate trial of imatinib mesylate or
• continuing treatment for patients of CML who have received treatment with PBS subsidised nilotinib.

The Schedule of Pharmaceutical Benefitsoutlines the restrictions for prescribing nilotinib.

View a full transcript of the nilotinib restriction details.

Nilotinib will only be PBS subsidised for patients with CML who are not receiving concomitant PBS subsidised imatinib mesylate, dasatinib or interferon alfa therapy.

From 1 November 2008, under the PBS, a patient will be able to trial either dasatinib and/or nilotinib within the intial 18 month treatment period, providing the patient’s CML is not resistant to the first second-line agent.

Nilotinib is not PBS subsidised for patients with CML that is resistant to dasatinib. 

Item details

Dose

The maximum dose that can be prescribed is 400 mg twice daily nilotinib is available in a capsule form presented as a pack size of 112.

Continuing therapy is dependent on patients demonstrating a response to nilotinib therapy, irrespective of the daily nilotinib dose received.

Repeats

Initial applications: a maximum of two repeats may be requested.

Continuing applications: a maximum of five repeats may be requested.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

• Who is eligible for the PBS?

Pathology reports

All applicable pathology reports must be provided from an approved Australian pathology authority.

Initial application: A pathology report which confirms that the patient has active disease and supporting pathology to demonstrate failure to an adequate trial of imatinib mesylate must be submitted.

Continuing application: A cytogenetic analysis on bone marrow or quantitative polymerase chain reaction (qPCR) on peripheral blood must be performed:

1. Between 10 and 18 months of initial treatment with nilotinib, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than one per cent has been demonstrated may receive authorisation for a further 12 months of treatment.
2. At no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than one per cent has been sustained.

Definitions of response:

• a major cytogenic response is defined as less than 35 per cent Philadelphia positive bone marrow cells
• a peripheral blood BCR-ABL level of less than one per cent on the international scale (Blood 108: 28-37, 2006 ) also indicates a response, at least the biological equivalent of a major cytogenetic response.

For bone marrow analyses where standard karyotyping conducted at the time of continuing application is not informative, a copy of a cytogenetic analysis conducted on bone marrow using Fluorescence In Situ Hybridisation (FISH) with BCR-ABL specific probe must be submitted with the application. A copy of the non-informative standard karyotype analysis must be included with the application.

Toxicity and severity descriptors

To ensure that the eligibility of patients can be fully assessed, a comprehensive list of imatinib mesylate toxicity criteria and severity descriptors [PDF, 77Kb] which should be used in conjunction with the application when demonstrating a Grade 3 or 4 non-haematological toxicity that is imatinib mesylate related, is attached. The toxicity must be of a severity to necessitate permanent treatment withdrawal.

Lodgement

All initial and continuing application requests must be in writing and sent to:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 9826
Hobart TAS 7001

(no stamp required if posted in Australia)

Please ensure that all applications for authorisation include:

• a completed authority prescription form
• a completed dasatinib/nilotinib supporting information form (which includes, for initial applications only, signed patient and prescriber acknowledgments)
• all relevant pathology reports to support current criteria.

For assistance please call 1800 700 270* and select option 3 (8 am to 5 pm EST Monday to Friday).

* Call charges apply from mobile or pay phones only.

Application forms

• Chronic myeloid leukaemia - dasatinib/nilotinib PBS authority application supporting information form - initial treatment - (Form 4190) [PDF, 213Kb]
  Lodge this form for a patient starting initial sole PBS subsidised treatment of chronic myeloid leukaemia with either dasatinib or nilotinib. The patient and prescriber acknowledgments must also be completed.
• Chronic myeloid leukaemia - dasatinib/nilotinib PBS authority application supporting information form - continuing treatment - (Form 4191) [PDF, 196Kb]
  Lodge this form for a patient continuing sole PBS subsidised treatment of chronic myeloid leukaemia with either dasatinib or nilotinib.

Important: The information on this website is correct at the time of publishing and is subject to change.

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Last updated: 21 January, 2009